Select therapeutic use:

Bladder, kidney, and other urologic cancers:

Indications for BAVENCIO:

First-line maintenance treatment of locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. Locally advanced or metastatic UC in patients who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In combination with axitinib for the first-line treatment of advanced renal cell carcinoma (RCC).

Adult Dosage:

Premedicate with an antihistamine and acetaminophen prior to the first 4 infusions; then subsequent doses as clinically indicated. Give as IV infusion over 60mins. 800mg every 2 weeks until disease progression or unacceptable toxicity. RCC: give in combination with axitinib 5mg every 12hrs (may increase axitinib dose at intervals of 2 weeks or longer). Dose modifications: see full labeling.

Children Dosage:

<12yrs: not established.

BAVENCIO Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. In combination with axitinib: risk of severe and fatal cardiovascular events; consider evaluating LVEF at baseline and periodically; discontinue both drugs if Grade 3/4 events occur. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥1 month after the last dose. Pregnancy. Nursing mothers: not recommended (during and for ≥1 month after the last dose).

BAVENCIO Classification:

Programmed death-ligand 1 (PD-L1) blocking antibody.

BAVENCIO Interactions:

Increased risk of hepatotoxicity and cardiovascular events (in combination with axitinib); monitor liver enzymes and LVEF more frequently.

Adverse Reactions:

Fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite, peripheral edema, UTI, hypertension, mucositis, palmar-plantar erythrodysesthesia, dysphonia, hypothyroidism, hepatotoxicity, cough, dyspnea, abdominal pain, headache; other immune-mediated adverse reactions (may be fatal).

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (10mL)—1

Melanoma and other skin cancers:

Indications for BAVENCIO:

Metastatic Merkel cell carcinoma (MCC).

Adult Dosage:

Premedicate with an antihistamine and acetaminophen prior to the first 4 infusions; then subsequent doses as clinically indicated. Give as IV infusion over 60mins. 800mg every 2 weeks until disease progression or unacceptable toxicity. Dose modifications: see full labeling.

Children Dosage:

<12yrs: not established.

BAVENCIO Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. In combination with axitinib: risk of severe and fatal cardiovascular events; consider evaluating LVEF at baseline and periodically; discontinue both drugs if Grade 3/4 events occur. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥1 month after the last dose. Pregnancy. Nursing mothers: not recommended (during and for ≥1 month after the last dose).

BAVENCIO Classification:

Programmed death-ligand 1 (PD-L1) blocking antibody.

BAVENCIO Interactions:

Increased risk of hepatotoxicity and cardiovascular events (in combination with axitinib); monitor liver enzymes and LVEF more frequently.

Adverse Reactions:

Fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite, peripheral edema, UTI, hypertension, mucositis, palmar-plantar erythrodysesthesia, dysphonia, hypothyroidism, hepatotoxicity, cough, dyspnea, abdominal pain, headache; other immune-mediated adverse reactions (may be fatal).

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (10mL)—1